Naltrexone: Important Safety Information
What is Naltrexone?
Naltrexone is an FDA-approved prescription medication used to help reduce the urge or desire to drink alcohol in people with alcohol use disorder. It may also be prescribed to support individuals who want to cut back on drinking. Naltrexone is not a cure for alcohol use disorder and should be used as part of a complete treatment plan that may include counseling, therapy, and behavioral support.
Important Safety Information
Do not take naltrexone if you:
Are currently dependent on opioids or are in opioid withdrawal.
Are using opioid pain medications, Suboxone, buprenorphine, methadone, or illicit opioids.
Have acute hepatitis or liver failure.
Are allergic to naltrexone or any of its ingredients.
Before starting naltrexone, tell your healthcare provider if you:
Use opioid-containing medicines for pain, cough, or diarrhea.
Have liver problems or hepatitis.
Are pregnant, plan to become pregnant, or are breastfeeding.
Have kidney problems.
Are taking any other medications, vitamins, or supplements.
Warnings and Precautions:
Taking opioids while on naltrexone can lead to sudden opioid withdrawal, which can be severe.
Using opioids after stopping naltrexone may increase the risk of overdose or death, even at lower doses than previously used.
Naltrexone may cause liver injury, especially at high doses. Tell your provider if you notice yellowing of your skin or eyes, dark urine, or stomach pain.
Naltrexone does not prevent withdrawal symptoms from alcohol.
Common side effects may include:
Nausea
Headache
Dizziness
Fatigue or sleep problems
Anxiety or irritability
Joint or muscle pain
If you experience severe side effects, signs of liver problems, or allergic reactions (rash, swelling, trouble breathing), stop taking naltrexone and seek medical help right away.
Additional Information
Always take naltrexone exactly as prescribed by your licensed clinician.
Avoid taking opioids or opioid-containing medicines while on naltrexone.
Do not start or stop any medications without consulting your clinician.
Discuss any side effects or concerns with your healthcare provider.
How to Report Side Effects
You may report side effects to the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
Prescribing Information
For complete prescribing information, please refer to the official FDA label:
Access the full Prescribing Information and Medication Guide (PDF)
Disclosure
Naltrexone is prescribed through Oar Health by licensed clinicians who determine whether it is appropriate for each patient. Oar Health does not manufacture medication; prescriptions are fulfilled through licensed U.S. pharmacies.
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Naltrexone is a prescription medication used to treat alcohol dependence. It is available only if prescribed by a healthcare provider. You should not take naltrexone if you use opioids, including prescription drugs or street drugs that contain opioids, as naltrexone can cause sudden opioid withdrawal. Common side effects of naltrexone include nausea, sleepiness, headache, dizziness, vomiting, decreased appetite, painful joints, muscle cramps, and trouble sleeping. These are not all of the side effects of naltrexone. Tell your healthcare provider if you have any side effects that bother you or do not go away.
